Effectiveness of URiSCAN 2 ACR strip test for albuminuria detection in screening of kidney disease
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Abstract
Albuminuria is a key marker for detection of kidney disease and an increased risk factor for cardiovascular diseases. Measurement of albumin/creatinine ratio (ACR) in urine is the best screening method to detect albuminuria. Nowadays, new version of URiSCAN 2 ACR strip test is developed to measure of albumin/creatinine ratio in urine and to report ACR value as semi-quantitative and quantitative results. Thus, we aimed to validate the effectiveness of the URiSCAN 2 ACR strip test by comparing with a quantitative automated analyzer, and to demonstrate the effectiveness of the strip test for screening chronic kidney disease in the community population. Measurements of ACR levels in 484 spot urine specimens of participants in CKDNET project were performed using the URiSCAN 2 Optima urine chemistry test system and using the SYNCHRON Lx20 PRO automated chemistry analyzer. The sensitivity, specificity, accuracy, positive predictive value and negative predictive value of URiSCAN 2 ACR strip to detect ACR were 93.2%, 62.9%, 67.6%, 31.2% and 98.1%, respectively. URiSCAN 2 ACR strip showed 63.0% concordance rate with quantitative automated assay, 68.8% false-positive and only 1.9% false-negative results. In addition, the best cut-off of ACR value for detection of chronic kidney disease using the urine strip test was in the range from 29.50 to 33.00 mg/g with area under the curve of 0.7413, while the area under the curve of quantitative automated analyzer was 0.7515. Sensitivity, specificity and accuracy of the strip test for detection of chronic kidney disease were 70.5%, 61.8% and 63.8%, respectively. URiSCAN 2 ACR strip provided a high sensitivity, high negative predictive value and few false negative results for detection of albuminuria. Thus, this ACR strip test might be served as an optimal method to rule-out microalbuminuria. However, diagnostic performance of URiSCAN 2 ACR strip test at cut-off of ACR >30 mg/g is fair for screening CKD in community population.
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